testing the safety of giving a standard dose of radiation over a shorter period of time for patients who had surgery for intermediate-risk head and neck cancer

Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Larynx; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Oral Cavity

Summary: this phase i trial is looking to determine if hypofractionated radiation therapy can be given safely after surgery for intermediate-risk head and neck cancer.

primary objective: i. to determine if a hypofractionated postoperative radiotherapy (h-port) schedule for patients with intermediate-risk head and neck cancer (squamous cell carcinoma of the oral cavity, oropharynx, or larynx) who have undergone surgery is safe and feasible for further evaluation in a phase ii clinical trial. secondary objectives: i. to assess h-port treatment-related and unrelated adverse events during treatment and within one year after treatment completion. ii. to assess h-port tolerability and compliance, as measured by treatment interruptions and discontinuations, and to assess the reasons for those modifications. arm i: patients undergo surgery per standard of care followed by hypofractionated radiotherapy. patients receive 50 gy over 4 weeks (i.e., 2.5 gy per day x 20 fractions). radiation therapy should start after there is adequate healing and no evidence of gross residual/recurrent cancer. patients are followed up at 1 month, 3 months, 6 months and 12 months post h-port therapy.

Eligibility criteria:
inclusion criteria: * pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma nos, etc.) of the head/neck (oral cavity, oropharynx or larynx); note: hypopharynx primaries are excluded because these patients have both a poor prognosis and high likelihood of post- radiation complications. * clinical stage i-iva squamous cell carcinoma of the oral cavity, oropharynx or larynx (ajcc 8th edition), including no distant metastases. * general history and physical examination prior to registration; * chest x-ray (at a minimum) or chest ct scan (with or without contrast) or pet/ct of chest (with or without contrast) prior to registration. * total resection of the patient's cancer (i.e. no residual disease after total resection of the patient's cancer). * one or more indications for postoperative radiotherapy, based upon pathologic findings: * perineural invasion; * lymphovascular invasion; * single lymph node ≥ 3 cm or ≥ 2 lymph nodes (no extracapsular extension); * close margin(s) of resection (close margins defined as cancer extending to within 5 mm of a surgical margin); * pathologically confirmed t3 or t4a primary tumor; * t2 oral cavity cancer with ≥ 5 mm depth of invasion. * zubrod performance status 0-1. * age 18-80. * negative pregnancy test within 14 days prior to registration for participants who may become pregnant. * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety assessment of the investigational regimen are eligible for this trial. * the patient or a legally authorized representative must provide study-specific informed consent prior to study entry. exclusion criteria: * recurrence of the study cancer. * history of systemic lupus erythematosus or systemic sclerosis (scleroderma). * pregnancy and individuals unwilling to discontinue nursing. * reliant on a feeding tube (gastric or jejuno) to maintain adequate nutrition at the time of registration * anticipated need for high-dose systemic chemotherapy (e.g., high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable. * prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; prior chemotherapy for study cancer is not allowed. * per the operative and/or pathology report, positive margin(s) \[defined as tumor present at the cut or inked edge of the tumor\], nodal extracapsular extension, and/or gross residual disease after surgery; note: patients whose tumors had focally positive margins in the main specimen but negative margins from re-excised samples in the region of the positive margin are eligible.